FDAS是什麼意思S在線翻譯讀音例句

DeviceClassification

Pleasenote:asofOctober1,2002,FDAchargesfeesforreviewof

PremarketNotification510(k)s1andPremarketApprovals2

ClassifyYourMedicalDevice

Introduction

HowToDetermineClassification

Int恶心的近义词 roduction

TheFoodandDrugAdministration(FDA)hasestablishedclassifications

forapproximately1,700differentgenerictypesofdevicesandgrouped

these

generictypesofdevicesisassignedtooneofthreeregulatoryclasses

basedonthelevelofcontrolnecessarytoassurethesafetyand

eeclassesandtherequirementswhich

applytothemare:

DeviceClassandRegulatoryControls

GeneralControls

oWithExemptions

oWithoutExemptions

IGeneralControlsandSpecialControls

oWithExemptions

oWithoutExemptions

IIGeneralControlsandPremarketApproval

Theclasstowhichyourdeviceisassigneddetermines,amongotherthings,

thetypeofpremarketingsubmission/applicationrequiredforFDA

deviceisclassifiedasClassIorII,and

ifitisnotexempt,ices

classifiedasexemptaresubjecttothelimitationsonexemptions.

Limitationsofdeviceexemptionsarecoveredunder21CFRxxx.9,where

ssIIIdevices,apremarketapproval

application(PMA)willberequiredunlessyourdeviceisapreamendments

device(onthemarketpriortothepassageofthemedicaldeviceamendments

i紧的反义词 n1976,orsubstantiallyequivalenttosuchadevice)andPMA\'shavenot

case,a510kwillbetheroutetomarket.

Deviceclassificationdependsontheintendeduseofthedeviceandalso

mple,ascalpel\'sintendeduseistocut

tofintendeduseariseswhenamorespecializedindication

isaddedinthedevice\'slabelingsuchas,\"formakingincisionsinthe

cornea\".Indicationsforusecanbefoundinthedevice\'slabeling,but

ssionof

themeaningofintendeduseiscontainedinPremarketNotificationReview

ProgramK86-33.

Inaddition,classificationisriskbased,thatis,theriskthedevice

posestothepatientand/ortheuserisamajorfactorintheclassit

includesdeviceswiththelowestriskandClassIII

includesthosewiththegreatestrisk.

AsindicatedaboveallclassesofdevicesassubjecttoGeneralControls.

GeneralControlsarethebaselinerequirementsoftheFood,Drugand

Cosmetic(FD&C)Actthatapplytoallmedicaldevices,ClassI,II,and

III.

HowtoDetermineClassification

Tofindtheclassificationofyourdevice,aswellaswhetherany

exemptionsmayexist,youneedtofindtheregulationnumberthatisthe

retwomethodsfor

accomplishingthis:godirectlytotheclassificationdatabase4andsearch

forapartofthedevicename,or,ifyouknowthedevicepanel5(medical

specialty)towhichyourdevicebelongs,godirectlytothelistingfor

maymakeachoicenow,orcontinuetoreadthebackgroundinformationbelow.

Ifyoucontinuetoread,youwillhaveanotherchancetogotothese

destinations.

IfyoualreadyknowtheappropriatepanelyoucangodirectlytotheCFR

andfindtheclassificationforyourdevicebyreadingthroughthelist

ofclassifieddevices,orifyou\'renotsure,youcanusethekeyword

casesthis

alsochecktheclassificationregulations7belowforinformationon

variousproductsandhowtheyareregulatedbyCDRH.

EachclassificationpanelintheCFRbeginswithalistofdevices

assifieddevicehasa7-digitnumber

,21CFR880.29208-ClinicalMercuryThermometer.

Onceyoufindyourdeviceinthepanel\'sbeginninglist,gotothesection

indicated:inthisexample,ribesthedevice

rly,intheClassificationDatabaseunder

\"thermometer\",you\'llseeseveralentriesforvarioustypesof

eeletterproductcode,FLKinthedatabasefor

ClinicalMercuryThermometer,isalsotheclassificationnumberwhichis

usedontheMedicalDeviceListingform.

OnceyouhaveidentifiedthecorrectclassificationregulationgotoWhat

aretheClassificationPanels10belowandclickonthecorrect

assI

devicesareexemptfromthepremarketnotificationand/orpartsofthe

imately572or74%ofthe

exemptionsarelistedintheclassificationregulationsof21CFRandalso

hasbeencollectedtogetherintheMedicalDeviceExemptions12document.

DeviceClassificationPanels

WhataretheClassificationPanels

HowtoLocateClassificationRegulations

WheretoProceedFromClassification

WhataretheClassificationPanels

Mostmedicaldevicescanbeclassifiedbyfindingthematchingdescription

ofthedeviceinTitle21oftheCodeofFederalRegulations(CFR),Parts

classifiedanddescribedover1,700distincttypesof

devicesandorganizedthemintheCFRinto16medicalspecialty\"panels\"

suchasCardiovasculardevicesorEar,Nose,

hofthe

devicesclassifiedbytheFDAtheCFRgivesageneraldescription

includingtheintendeduse,,

ClassI,II,orIII),

deviceshouldmeetthedefinitioninaclassificationregulation

containedin21CFR862-892.

HowtoLocateClassificationRegulations

8681Anesthesiology

8702Cardiovascular

8623ClinicalChemistryandClinicalToxicology

8724Dental

8745Ear,Nose,andThroat

8766GastroenterologyandUrology

8787GeneralandPlasticSurgery

8808GeneralHospitalandPersonalUse

8649HematologyandPathology

86610ImmunologyandMicrobiology

88211Neurology

88412ObstetricalandGynecological

88613Ophthalmic

88814Orthopedic

89015PhysicalMedicine

89216Radiology

WheretoProceedFromClassification

Ifyourdevicerequirespremarketnotification[510(k)]proceedtothe

PremarketNotification[510(k)]ssIdevicesexemptfrom

[510(k)]thesubmissionofa[510(k)]andmarketingclearancefromFDA

ClassI(orcertainclassII)deviceisexempt,

subjecttothelimitationsonexemptions,fromthe510(k)process,this

r,otherGeneral

Controlssuchasregistrationandlisting17,labeling18,andgood

aveaClassIIIdevicerequiring

premarketapproval(PMA)proceedtoPremarketApproval(PMA)page.

Marketsubmissionoptions

510(k)20

PMA21

Exempt22

PremarketNotification(510k)

Introduction

WhatisSubstantialEquivalence

WhoisRequiredtoSubmita510(k)

Whena510(k)isRequired

Whena510(k)isnotRequired

ThirdPartyReviewProgram

Introduction

EachpersonwhowantstomarketintheU.S.,aClassI,II,andIIIdevice

intendedforhumanuse,forwhichaPremarketApproval(PMA)isnot

required,mustsubmita510(k)toFDAunlessthedeviceisexemptfrom

510(k)requirementsoftheFederalFood,Drug,andCosmeticAct(theAct)

anddoesnotexceedthelimitati孟子生于忧患 onsofexemptionsin.9ofthedevice

,21CFR862.9,21CFR864.9).

Thereisno510(k)form,however,21CFR8071SubpartEdescribes

requirementsfora510(k)marketingadevice,each

submittermustreceiveanorder,intheformofaletter,fromFDAwhich

findsthedevicetobesubstantiallyequivalent(SE)andstatesthatthe

der\"clears\"thedevicefor

commercialdistribution.

A510(k)isapremarketsubmissionmadetoFDAtodemonstratethatthe

devicetobemarketedisatleastassafeandeffective,thatis,

substantiallyequivalent,toalegallymarketeddevice(21CFR

807.92(a)(3))tersmustcomparetheir

devicetooneormoresimilarlegallymarketeddevicesandmakeandsupport

lymarketeddevice,as

describedin21CFR807.92(a)(3),isadevicethatwaslegallymarketed

priortoMay28,1976(preamendmentsdevice),forwhichaPMAisnot

required,oradevicewhichhasbeenreclassifiedfromClassIIItoClass

IIorI,oradevicewhichhasbeenfoundSEthroughthe510(k)

allymarketeddevice(s)towhichequivalenceisdrawn

iscommonlyknownasthe\"predicate.\"Althoughdevicesrecentlycleared

under510(k)areoftenselectedasthepredicatetowhichequivalenceis

claimed,y

marketedalsomeansthatthepredicatecannotbeonethatisinviolation

oftheAct.

UntilthesubmitterreceivesanorderdeclaringadeviceSE,thesubmitter

edevic纳兰容若的绝美诗句 eisdeterminedto

beSE,eterminationisusually

madewithin90daysandismadebasedontheinformationsubmittedbythe

submitter.

PleasenotethatFDAdoesnotperform510(k)p苏轼的诗词江城子 re-clearancefacility

mittermaymarketthedeviceimmediatelyafter510(k)

ufacturershouldbepreparedforanFDA

qualitysystem(21CFR820)inspectionatanytimeafter510(k)clearance.

WhatisSubstantialEquivalence

A510(k)requiresdemonstrationofsubstantialequivalencetoanother

ntialequivalencemeansthatthenew

deviceisatleastassafeandeffectiveasthepredicate.

Adeviceissubstantiallyequivalentif,incomparisontoapredicateit:

hasthesameintendeduseasthepredicate;and

hasthesametechnologicalcharacteristicsasthepredicate;

or

hasthesameintendeduseasthepredicate;and

hasdifferenttechnologicalcharacteristicsandtheinformationsubmittedtoFDA;

odoesnotraisenewquestionsofsafetyandeffectiveness;and

odemonstratesthatthedeviceisatleastassafeandeffectiveasthelegally

marketeddevice.

Aclaimofsubstantialequivalencedoesnotmeanthenewandpredicate

ntialequivalenceisestablishedwith

respecttointendeduse,design,energyusedordelivered,materials,

chemicalcomposition,manufacturingprocess,performance,safety,

effectiveness,labeling,biocompatibility,standards,andother

characteristics,asapplicable.

hesubmitterreceivesa

etermines

thatadeviceisnotsubstantiallyequivalent,theapplicantmay:

oresubmitanother510(k)withnewdata,

orequestaClassIorIIdesignationthroughthedenovo2process

ofileareclassificationpetition3,or

osubmitapremarketapprovalapplication(PMA).

WhoisRequiredtoSubmita510(k)

TheActandthe510(k)regulation(21CFR807)donotspecifywhomust

applyfora510(k).Instead,theyspecifywhichactions,suchas

,requirea510(k)submission.

Thefollowingfourcategoriesofpartiesmustsubmita510(k)totheFDA:

;

Finisheddevicemanufacturersmustsubmita510(k)iftheymanufactureadevice

oriestofinished

r,

manufacturersofdevicecomponentsarenotrequiredtosubmita510(k)unlesssuch

ct

manufacturers,thosefirmsthatmanufacturedevicesundercontractaccordingtosomeone

else’sspecifications,arenotrequiredtosubmita510(k).

;

Aspecificationdeveloperdevelopsthespecificationsforafinisheddevice,buthasthe

cificationdeveloper

submitsthe510(k),notthecontractmanufacturer.

ersorrelabelerswhomakelabelingchangesorwhoseoperationssignificantly

affectthedevice.

Repackagersorrelabelersmayberequiredtosubmita510(k)iftheysignificantlychange

icantlabelingchanges

mayincludemodificationofmanuals,suchasaddinganewintendeduse,deletingor

addingwarnings,contraindications,ions,suchassterilization,couldalterthe

r,mostrepackagersorrelabelersarenotrequiredto

submita510(k).

nmanufacturers/entativesofforeign

manufacturers/.

Pleasenotethatallmanufacturers(includingspecificationdevelopers)

ofClassIIandIIIdevicesandselectClassIdevicesarerequiredto

followdesigncontrols(21CFR820.30)duringthedevelopmentoftheir

derofa510(k)musthavedesigncontroldocumentation

tion,any

changestothedevicespecificationsormanufacturingprocessesmustbe

madeinaccordancewiththeQualitySystemregulation(21CFR820)and

maybesubjecttoanew510(k).Pleaseseeourguidance,\"DecidingWhen

toSubmita510(k)foraChangetoanExistingDevice4.\"

Whena510(k)isRequired

A510(k)isrequiredwhen:

ucingadeviceintocommercialdistribution(marketing)

May28,1976(effectivedateoftheMedicalDeviceAmendmentstotheAct),anyonewho

iredtomakea510(k)submissionatleast90days

priortoofferingthedeviceforsale,eventhoughitmayhavebeenunderdevelopmentor

devicewasnotmarketedbyyourfirm

beforeMay28,1976,a510(k)isrequired.

poseadifferentintendeduseforadevicewhichyoualreadyhaveincommercial

510(k)regulation(21CFR8075)specificallyrequiresa510(k)

eduseisindicated

,ifnotallchangesin

intendedusewillrequirea510(k).Pleasenotethatprescriptionusetooverthecounter

useisamajorchangeinintendeduseandrequiresthesubmissionofanew510(k).

sachangeormodificationofalegallymarketeddeviceandthatchangecould

denisonthe510(k)holderto

decidewhetherornotamodificationcouldsignificantlyaffectsafetyoreffectivenessof

ificationsmustbemadeinaccordancewiththeQualitySystem

regulation,21CFR820,andrecordedinthedevicemasterrecordandchangecontrol

commendedthatthejustificationforsubmittingornotsubmittinganew

510(k)berecordedinthechangecontrolrecords.

Anew510(k)submissionisrequiredforchangesormodificationstoanexistingdevice,

wherethemodificationscouldsignificantlyaffectthesafetyoreffectivenessofthedevice

new

510(k)requiredforamodificationtothedevice?6foradditionalinformation.

Whena510(k)isNotRequired

Thefollowingareexamplesofwhena510(k)isnotrequired.

lunfinisheddevi聊斋志异画皮 cestoanotherfirmforfurtherprocessingorsellcomponents东方未明 to

r,ifyourcomponentsareto

besolddirectlytoendusersasreplacementparts,a510(k)isrequired.

otneeda510(k)

todevelop,evaluate,notethatif

youperformclinicaltrialswithyourdevice,youaresubjecttotheInvestigationalDevice

Exemption7(IDE)regulation(21CFR812).

tributeanotherfirm\'placealabelon

thedevice,\"DistributedbyABCFirm\"or\"ManufacturedforABCFirm,\"(21CFR801.18)

andsellittoenduserswithoutsubmissionofa510(k).

cases,ifyouarearepackagerorarelabeleryouarenotrequiredtosubmita

510(k)ifthe

labelingshouldbeconsistentwiththelabelingsubmittedinthe510(k)withthesame

indicationsforuseandwarningsandcontraindications.

vicewaslegallyincommercialdistributionbeforeMay28,1976andyouhave

evicesare\"grandfathered\"andhavePreamendment

othavetosubmita510(k)unlessthedevicehasbeensignificantly

modifiedortherehasbeenachangeinitsintendeduse.

areanimporteroftheforeignmademedical

device.A510(k)isnotrequiredifa510(k)hasbeensubmittedbytheforeign

eforeignmanufacturerhas

received510(k)clearanceforthedevice,theforeignmanufacturermayexporthisdevice

er.

viceisexemptedfrom510(k)byregulation(21CFR862-892).Thatis,certain

ClassIorIIdevicescanbemarketedforthefirsttimewithouthavingtosubmita510(k).

AlistoftheClassIandIIexempteddevicescanbefoundonMedicalDeviceExemptions

510(k)r,ifthedeviceexceedsthelimitationsof

exemptionsin.,21CFR862.9,21

CFR864.9),suchasthedevicehasanewintendeduseoroperatesusingadifferent

fundamentalscientifictechnologythanalegallymarketeddeviceinthatgenerictypeof

device,orthedeviceisareprocessedsingle-usedevice,thena510(k)mustbesubmitted

tomarketthenewdevice.

PreamendmentDevices

Theterm\"preamendmentsdevice\"referstodeviceslegallymarketedinthe

mbeforeMay28,1976andwhichhavenotbeen:

significantlychangedormodifiedsincethen;and

forwhicharegulationrequiringaPMAapplicationhasnotbeenpublishedbyFDA.

Devicesmeetingtheabovecriteriaarereferredtoas\"grandfathered\"

devicesanddonotrequirea510(k).Thedevicemusthavethesameintended

useasthatmarketedbeforeMay28,eviceislabeledfor

anewintendeduse,thenthedeviceisconsideredanewdeviceanda510(k)

mustbesubmittedtoFDAformarketingclearance.

Pleasenotethatyoumustbetheownerofthedeviceonthemarketbefore

May28,1976,deviceissimilar

toagrandfathereddeviceandmarketedafterMay28,1976,thenyourdevice

doesNOTmeettherequirementsofbeinggrandfatheredandyoumustsubmit

a510(k).Inorderforafirmtoclaimthatithasapreamendmentsdevice,

itmustdemonstratethatitsdevicewaslabeled,promoted,anddistributed

ininterstatecommerceforaspecificintendeduseandthatintendeduse

amendmentStatus11forinformationon

documentationrequirements.

ThirdPartyReviewProgram

TheCenterforDevicesandRadiologicalHealth(CDRH)hasimplementeda

ogramprovidesanoptionto

manufacturersofcertaindevicesofsubmittingtheir510(k)toprivate

parties(RecognizedThirdParties)identifiedbyFDAforreviewinstead

einformationontheprogram,

eligibledevicesandalistofRecognizedThirdPartiesgotoThirdParty

ReviewProgramInformation12page.

-

References

510(k)FrequentlyAskedQuestions13

NewSection513(f)(2)-EvaluationofAutomatic稚子弄冰改写成小短文 ClassIIIDesignation,Guidancefor

IndustryandCDRHStaff14

510(k)SubstantialEquivalenceDecisionMakingProcessFlowChartDetailed(PDF-

31KB)15

GuidanceontheCDRHPremarketNotificationReviewProgram6/30/86(K86-3)16

DecidingWhentoSubmita510(k)foraChangetoanExistingDevice(K97-1)17

PreamendmentStatus18

-

-

AdditionalInformation

510(k)Clearances19